Industry news

• The Ministry of Health proposes to sell only proven effective dietary supplements

  11 September 2024 GxP news

  The Russian Ministry of Health has introduced amendments for the second reading of the bill that regulates the biologically active additives (BAA) market. According to these changes, only those BAA’s whose effectiveness has been confirmed by research will be allowed for sale. Expert organizations will evaluate the results of these studies to ensure the supplements’ effects on the body before they are released to the market.

• Gene therapy trial facilitates major vision improvement

  11 September 2024 Catherine Eckford / European Pharmaceutical Review

  Some of the rare disease participants experienced fast and sustained improvement in their eyesight during the clinical trial, data shows.

• Eight radiopharmaceuticals registered in Russia since 2023

  10 September 2024 GxP news

  According to Russian Health Minister Mikhail Murashko, 62 radiopharmaceuticals have been officially approved for use in Russia. Just last year, only 54 were registered, with 90% being domestically manufactured.

• First-in-class combination therapy authorised for endometriosis

  10 September 2024 Catherine Eckford / European Pharmaceutical Review

  The three-in-one oral daily tablet provides an additional treatment option to help women in the UK manage their endometriosis-associated pain.

• Russian cancer vaccine passes preclinical trials

  09 September 2024 GxP news

  Clinical trials for a cancer vaccine in Russia will soon commence, following the approval of the Russian Ministry of Health. The chief oncologist of the Ministry of Health and the general director of the National Medical Research Center of Radiology, Andrey Kaprin, made this announcement during a press conference commemorating the center’s 10th anniversary. 

• Gene therapy trial facilitates major vision improvement

  09 September 2024 Catherine Eckford / European Pharmaceutical Review

  Some of the rare disease participants experienced fast and sustained improvement in their eyesight during the clinical trial, data shows.

• A preclinical research center was created at Siberian State Medical University following GLP standards

  06 September 2024 GxP news

  The Siberian State Medical University (SSMU) in Tomsk has inaugurated a new Preclinical Research Center, facilitating interdisciplinary research on various animal species. The site is certified in accordance with GLP requirements.

• HPV vaccine is to be included in Russia’s national immunization schedule by 2026

  06 September 2024 GxP news

  The human papillomavirus (HPV) vaccine is set to be included in Russia’s National Immunization Schedule by 2026, according to Elena Uvarova, the Chief Pediatric and Adolescent Gynecologist at the Russian Ministry of Health. “Currently, the HPV vaccine is not part of the national schedule, but a tentative date has been set for 2026 to include it alongside other vaccines in the National Immunization Schedule,” Uvarova announced at a press conference on Friday

• New WHO guidance to support manufacturers to reduce AMR risk

  05 September 2024 Catherine Eckford / European Pharmaceutical Review

  The recommendations offered in the guidance is applicable across different areas of manufacturing, from active pharmaceutical ingredients (APIs), through to formulation and packaging.

• Russian Direct Investment Fund to assist localization of Russian pharmaceutical production in Mongolia

  05 September 2024 GxP news

  The Russian Direct Investment Fund (RDIF) and the Mongolian pharmaceutical company MEIC have agreed to cooperate in this area. The partnership includes collaborative investments in initiatives to transfer technology and localize the production of Russian pharmaceuticals in Mongolia.